FDA Biosimilar Approval of Inflectra Viewed as a Milestone Advance

Save

On February 9th, the Food and Drug Administration (FDA) Arthritis Advisory Committee voted 21-3 in favor of approving the infliximab biosimilar, CT-P13/Inflectra, for use in all of infliximab's indications.

The Week in Review - 1 April 2016

Save

Highlights from this week on RheumNow.com

Biologics Are Safe When Used During Pregnancy in IBD

Save

This is a reposting of an earlier report on RheumNow that includes additional commentary from Dr. Sunada Kane, a gastroenterologist at the Mayo Clinic who specializes in both inflammatory bowel disease (IBD) and pregnancy. 

Week in Review - 25 March 2016

Save

1. phase 3, BRIDGE study shows romosozumab (anti-sclerostin MAb) significantly increases lumbar BMD in men with osteoporosis


2. Statin use is associated with a 21% increased risk of skin cancer (NMSC) - data

First Head-to-Head TNF Trial Ends in a Draw

Save

Comparative efficacy trials may be the best way to make informed treatment choices in a sea of treatment options for rheumatoid arthritis (RA).  Recent years have seen impressive head-to-head (H2H) clinical trials for RA, including AMPLE (abatacept vs.

The Week in Review 18 March 2016

Save

See the highlights from the past week that appeared on RheumNow.com, and watch Dr. Jack Cush as he reviews each of them. 

TNF Inhibitors Increase Perioperative Infection Risk

Save

The use of tumour necrosis factor α inhibitors (TNFis) at the time of major surgery has been a challenge for surgeons, rheumatologists and those wishing to develop evidence-based guidelines for this clinical scenario.

ACR Invites Comment on Perioperative Management Guidelines

Save

The ACR is inviting members and rheumatologists to comment on their proposal to develop recommendations for the "Perioperative Management of Rheumatic Disease Medications in Total Joint Arthroplasty of the Hip and Knee".   

Biosimilars Reviewed by Expert Panel

Save

As the number of biosimilars in development keeps on growing, reaching nearly 700 products to date, demand for data from randomized controlled trials (RCTs) and an understanding of these new biologics  is peaking the interest of many. 

The Week in Review - 4 March 2016

Save

Highlights from this week on RheumNow:

TNF Inhibition and Heart Failure

Save

Clinicians often face the issue of using a TNF inhibitor (TNFi) in patients with heart failure or cardiac disease. Here are the facts and data necessary to make a cogent decision to use or avoid TNFi.

Less Treatment, Responses and Safety in Elder-Onset Rheumatoid Arthritis

Save

A recent review compared elderly-onset rheumatoid arthritis (EORA) to those with younger-onset rheumatoid arthritis (YORA) to assess treatment responses and safety issues with biologics and DMARDS. EORA is generally defined as the onset of rheumatoid arthritis after age 60 years.

RA Flares Common After Anti-TNF Withdrawal

Save

The risk of a flare increased by more than three-fold over 1 year when patients with longstanding rheumatoid arthritis (RA) in remission, or with stable low disease activity, stopped their anti-tumor necrosis factor (TNF) treatment, Dutch researchers reported.

RWCS 2016 – Rheumatoid Review, Psoriatic Arthritis and Medical Marijuana

Save

The Rheumatology Winter Clinical Symposia launched its 9th annual conference yesterday in Maui. Highlights of this meeting will be covered by RheumNow from Wednesday 2/10 till Saturday 2/13.

Rheumatoid Arthritis Year in Review

Rheumatoid Modern Management is Better but More Costly

Save

The mantra of rheumatologists worldwide is to treat rheumatoid arthritis (RA) earlier and more aggressively. While referral of early RA patients has improved, there is little data demonstrating that more aggressive treatment works or is cost effective.

FDA Advisory Arthritis Committee Votes to Approve the CT-P13 (infliximab) Biosimilar

Save

On Tuesday February 9th Celltrion presented its biosimilar developmental data to the FDA as they sought approval for their CT-P13 (called Inflectra), a biosimilar of infliximab (Remicade).

FDA Reviews Celltrion's Remicade Biosimilar Today

Save

The arthritis advisory committee of the Food and Drug Administration (FDA) is scheduled to meet today, February 9th to review the efficacy and safety of Celltrion's biosimilar form of infliximab (Remicade) that is currently marketed in other countries.

Rheumatoid Arthritis, TNF inhibitors and the Risk of Skin Cancer

Save

Rheumatoid arthritis (RA) patients are said to have a neutral risk for neoplasia, but this is because they have a lower risk of colon cancer and breast cancer but a higher risk of lung cancer, lymphoma and skin cancers.

No Significant Increased Risk with TNF Inhibitors During Pregnancy

Save

A population-based study of 1,272,424 live-born infants from Denmark and Sweden examined the prevalence of birth defects among infants born to 683 women with chronic inflammatory disease (inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis)

Updated RA Treat-to-Target International Recommendations

Save

In 2010, Smolen and a group of international rheumatologists developed a series of recommendations addressing the concept of treat-to-target (T2T) in the management of rheumatoid arthritis (RA).